GMP requirements in Asia – Focus Japan, China

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 11, Seite 1279 (2022))

Bock M

GMP requirements in Asia – Focus Japan, China / Bock • GMP requirements · Bock M · MB Consult Augst, Augst (Switzerland)
Almost all countries in the world follow the harmonized GxP standards of the World Health Organization (WHO) and have implemented respective rules in their guidelines. Nevertheless, there are some slight differences from country to country mainly influenced by the respective cultures in these countries. Religion, political systems, and history have noteworthy influence on that. Japan is known for high quality with the target of zero defect which makes it difficult for foreign suppliers to achieve these requirements. China is hesitating to import materials from abroad and the import license registration of a new material can take several years. On the ...

How to deal with different GMP requirements of important countries in a Manufacturing and Supply Strategy

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 03, Seite 330 (2019))

Bock M

How to deal with different GMP requirements of important countries in a Manufacturing and Supply Strategy / Bock • GMP Requirements · Bock M · Augst, Switzerland
Global network strategy: Sites are dedicated to a global supply with probably one high global GMP standard. Idle capacity might be minimized. Regional network strategy: Plants in strategic countries produce only for their region. They fulfill GMP requirements of the countries of their customers. This does not mean a lower product quality. A company will always strive to ensure patient safety. Logistic costs might be lower in a regional setup. A mixed strategy means to dedicate some plants to global supply and some to regional supply. Globale Netzwerkstrategie: Fabriken produzieren für eine globale Versorgung mit einem hohen globalen GMP-Standard. Die ...